The Research Methods core will support clinical and translational investigators by providing Biostatistics, Epidemiology, and Research Design (BERD)-related and regulatory knowledge. The overall objective of the BERD program is to enhance the success of clinical and translational research through collaborative support in biostatistics and epidemiology, BERD education and training, and the development and dissemination of innovative analytical methods incorporating novel data sources. BERD will leverage its strong and vibrant links with the research faculty at GaCTSA?s partner institutions to efficiently connect GaCTSA researchers with a diverse community of quantitative experts dedicated to promoting the overall GaCTSA mission. The following areas of expertise will be supported by the BERD faculty: biostatistics; analytical epidemiology; and research design, including clinical trials, pragmatic clinical trials, implementation science; bioinformatics; social network analysis; and health services research. Regulatory Knowledge and Support (RKS) will provide regulatory knowledge and support to GaCTSA investigators and institutions. In collaboration with the Quality and Efficiency Function, RKS also facilitates research compliance by GaCTSA investigators with institutional and IRB policies, state laws, and federal regulations. Several innovative activities are proposed in this application to support identified needs of investigators including: reducing regulatory and compliance barriers; expanding regulatory science support to GaCTSA investigators and GaCTSA-institutional IRBs developing emerging technologies; and expanding local, regional, and national research ethics educational activities.